Kornimate/medical-research-clean huggingface dataset:
adjuvant chemotherapy regimens in resected biliary tract cancers (tog/gi-safradju-2501)

Conditions: Biliary Tract Cancer; Biliary Tract Cancers (BTC)

Summary: the goal of this observational study is to compare chemotherapy types that are given after surgery for biliary tract cancers. the main question it aims to answer is: are any of the chemotherapy regimens more effective in preventing recurrence, providing longer survival, or having less toxicity? nationwide multicenter retrospective data will be collected.


Eligibility criteria:
inclusion criteria: * histologically confirmed biliary tract cancer (intrahepatic, perihilar, distal, gallbladder) * underwent curative-intent resection exclusion criteria: * patients with a disease without histological confirmation * ampullary cancers
a trial of zl-1201 in subjects with advanced cancer

Conditions: Advanced Cancer

Summary: first in human, phase i trial of zl-1201 in subjects with advanced cancer

this is a first-in-human, dose escalation trial of zl-1201. the major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.

Eligibility criteria:
inclusion criteria: * histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors and lymphomas that are refractory or intolerant to standard of care therapy, or for which no standard therapy exists. * adequate hematologic status * adequate coagulation function * adequate hepatic function * adequate renal function exclusion criteria: * known active brain metastases * red blood cells transfusion dependence * known cardiopulmonary disease * pregnant or breast-feeding females * any other serious underlying medical

Keywords: advanced solid tumors or hematologic malignancies
maternal effects of bacterial vaginosis (bv) treatment in pregnancy

Conditions: Vaginosis, Bacterial; Premature Birth; Birth Weight; Chorioamnionitis

Summary: the goal of this study is to examine acceptability and efficacy of 2 kinds of bv treatment among women at low risk for preterm delivery. the objectives are: 1. to examine the side effects and patient acceptability of oral versus intravaginal metronidazole. 2. to compare the efficacy of oral and intravaginal metronidazole for the treatment of bv 3. to study the efficacy of oral and intravaginal metronidazole for the prevention of hospital admission during the 3rd trimester, chorioamnionitis, preterm delivery, and maternal infectious morbidity.

this is a randomized, placebo-controlled intervention trial. women diagnosed as bv+ by gram stain at 12-16 weeks gestation are randomly assigned to the following treatment groups: oral metronidazole (250 mg tid x 7 days) with intravaginal placebo; intravaginal metronidazole (5g 0.75% gel bid x 5 days) with oral placebo. african american, hispanic, asian/pacific islander, native american, and white women are eligible. women with a prior preterm delivery, multiple gestation, chronic hypertension or pre-existing diabetes, antibiotic use before enrollment in the study, allergy to metronidazole, history of alcohol abuse in past year, and women under age 18 are excluded.

Eligibility criteria:
inclusion criteria: * tested positive for bacerial vaginosis (nugent score \>7) * african american, hispanic, asian/pacific islander, native american, and white women exclusion criteria: * \>20 weeks gestaion * history of preterm delivery * had a multiple gestation pregnancy * had major medical complications (e.g., chronic hypertension or pre-existing diabetes) * antibiotic use within 7 days of screening visit for enrollment in the study, * allergy to metronidazole * history of alcohol dependency in past year women under age 16

Keywords: bacterial vaginosis metronidazole
a prospective,randomised, open label study for comparison of the incidence and severity of postoperative sore throat (post) using c-mac video laryngoscope and traditional macintosh laryngoscope for intubation

Conditions: Hoarseness of Voice; Sore-throat

Summary: the aim of this study is to compare the incidence of postoperative sore throat after intubation with two different types of laryngoscopes.

postoperative sore throat is a well known complication after endotracheal intubation. one of the major contributing factors is trauma associated with laryngoscopy. with decreased force applied to visualise cords, video laryngoscopes should decrease the incidence of postoperative sore throat. in this study we compared the incidence and severity of postoperative sore throat when laryngoscopy was done using c-mac video laryngoscope d-blade( group v) versus macintosh laryngoscope (group m). method: fifty four american society of anaesthesiologists (asa) 1\&2 patients between age 18-60 years , undergoing laproscopic surgeries of short duration were included in this study and laryngoscopy was done with macintosh laryngoscope in m group and with c mac video laryngoscope d blade in v group. patients were followed up 2hours, 6hours, 12hours and 24hours in postoperative period to see postoperative sore throat and hoarseness of voice .

Eligibility criteria:
inclusion criteria: * age more than 18 years * american society of anaesthesiologists(asa)1 and 2 * mallampati (mpc) grading 1 and 2 * laparoscopic cholecystectomy and appendectomy * surgeries of short duration(\<2hour) exclusion criteria: * patients refusing to give consent * pregnant and lactating patients * patients with severe co-morbidities requiring postoperative ventilatory support

Keywords: endotracheal tube postoperative sore throat hoarseness of voice macintosh laryngoscope c-mac video laryngoscope
the effectiveness of sedation and analgesia in colonoscopy treatment of colorectal polyps

Conditions: Colonoscopy; Sedation and Analgesia

Summary: this study aims to evaluate the effectiveness of sedation and analgesia in the treament of colorectal polyps by colonoscopy.

colorectal polyps are precancerous lesions of the colorectal cancer. colonoscopy can reduce the risk of colorectal cancer. painless endoscopy could reduce patient discomfort and improves the acceptance of treatment, especially for the endoscopic treatment of colorectal polyps. intravenous anesthesia colonoscopy has a strong sedative effect and has obvious inhibitory effects on the respiratory and circulatory systems. it requires the assistance of an anesthesiologist. the lack of anesthesiologists makes it difficult to make an appointment for anesthesia colonoscopy, which is a bottleneck in the diagnosis and treatment of gastrointestinal diseases in china. therefore, there is an urgent need to find a painless diagnosis and treatment method that is not inferior to anesthesia colonoscopy in comfort to meet the needs of patients. comparing to anesthesia colonoscopy, sedative and analgesic colonoscopy have similar sedative and analgesic effects and do not require the assistance of an anesthesiologist. however, there is no relevant evaluation on the effectiveness of sedation and analgesia during the endoscopic treatment of colorectal polyps. our department has used midazolam combined with dezocine to treat 185 patients with colorectal polyps in these years. retrospective analysis showed that the sedative and analgesic effect is satisfactory. therefore, it is necessary to make a single-center randomized parallel group controlled non-inferiority study to directly compare the effectiveness of sedation and analgesia versus intravenous anesthesia in endoscopic treatment of colorectal polyps.

Eligibility criteria:
inclusion criteria: * colonoscopy diagnosed as a colorectal polyp, the number of polyps is less than 5, and the size of single polyp is less than 2.0 cm * age more than 18 years and less than 70 years exclusion criteria: * allergy to propofol, dezocine, midazolam or eggs * asa class iv, short and tick neck, difficult intubation due to inability to open the mouth widely * suspected of gastrointestinal perforation, bleeding or obstruction * acute gastrointestinal infection period * history of abdominal surgery * patients during pregnancy or lactation
proprioception and meditation

Conditions: Parkinson Disease; Proprioceptive Disorders; Movement Disorders

Summary: in past work is has been shown that yoga can be as effective as a standard balance or tai chi protocol; however, there is an inability to distinguish between the mind and body contributions of yoga training. this study will compare an accepted proprioceptive training program to a meditation program which concentrates on body awareness in individuals with parkinson's disease.


Eligibility criteria:
inclusion criteria: * an individual must be between 40 and 90 years of age with mild to moderate parkinson's disease (hoehn \& yahr stages i-iii). exclusion criteria: * participants that have been part of a formal training program that targeted lower body strength, balance or proprioception within the past six months * participants that have any uncontrolled nerve (except parkinson's patients taking appropriate medication), bone or joint, or heart disease; * participants that have been advised by a doctor to not exercise; * participants that have regularly practiced yoga at least twice per week within the past six months; * participants that is unable to consent; * participants that is a prisoner; * participants that are pregnant.
a study to assess the long-term safety of tacrolimus cream in the treatment of psoriasis

Conditions: Psoriasis

Summary: a study to assess the long-term safety of tacrolimus cream in the treatment of psoriasis

a long-term, open label, non-comparative, multi-center study to evaluate the safety of tacrolimus cream-b 0.1% in treating the signs and symptoms of psoriasis.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of plaque psoriasis exclusion criteria: * skin disorder other than plaque psoriasis in the areas to be treated. * disease on only scalp

Keywords: treatment outcome tacrolimus safety psoriasis
neuroprosthetic device for improving issues caused by diabetic neuropathy with specifically designed neural stimulation

Conditions: Neuropathy;Peripheral; Neuropathy, Diabetic; Neuropathy, Painful

Summary: neuropathy refers to a condition that results from damage to the peripheral nerves.the most common cause of it is diabetes mellitus, metabolic disorder that affects more than 422 million individuals worldwide, putting a huge strain on the healthcare system and up to 50% of these individuals will develop neuropathy. peripheral neuropathy is characterized by sensory nerve abnormalities such as an impaired sense of touch. sensory loss in feet can lead to functional deficits during gait, low balance, and increased risk of falls and is considered the strongest risk factor for diabetic foot ulceration. moreover, these patients usually also suffer from neuropathic pain, which is believed to be associated with aberrant sensory input. with this in mind, the study aims to understand the effects of restoring sensation lost to neuropathy using transcutaneous electrical stimulation. additionally, the investigators aim to understand if electrical stimulation of the damaged nerves can reduce health consequences such as chronic pain. to achieve this, the investigators have developed a wearable sensory restoration system that can restore lost sensation with non-invasive, precisely controlled electrical stimulation through electrodes integrated into the sock garment. a system is composed of a system controller that communicates via bluetooth with force-sensitive insoles placed in the shoes and neurostimulators directly connected to electrode array socks. based on the insole recordings the stimulation parameters are defined in real-time, making it a closed-loop system for restoring somatotopic sensory feedback.


Eligibility criteria:
inclusion criteria: * diagnosed polyneuropathy * ability to stand and walk unassisted. * sensory loss in the feet exclusion criteria: * open ulcers on the feet * pregnancy * history of or current psychological diseases that include schizophrenia and major depression * hypersensitivity to electrical stimulation
phenobarbital for acute alcohol withdrawal

Conditions: Alcohol Withdrawal

Summary: intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based alcohol withdrawal protocol will be associated with decreased need for icu admission, continuous lorazepam infusion and will not be associated with increased adverse events.


Eligibility criteria:
inclusion criteria: * need for admission to hospital for acute alcohol withdrawal exclusion criteria: * allergy to phenobarbital, lorazepam, age\ 65
magnetic acupressure in reducing pain in cancer patients undergoing bone marrow aspiration and biopsy

Conditions: Hematopoietic/Lymphoid Cancer; Pain

Summary: rationale: acupressure may help relieve pain in cancer patients undergoing bone marrow aspiration and biopsy. it is not yet known whether magnetic acupressure is more effective than sham acupressure in reducing pain in cancer patients undergoing bone marrow aspiration and biopsy. purpose: this randomized clinical trial is studying magnetic acupressure to see how well it works compared with sham acupressure in reducing pain in cancer patients undergoing bone marrow aspiration and biopsy.

objectives: primary * to compare pain rating in cancer patients undergoing bone marrow aspiration and biopsy (bmab) treated with magnetic acupressure at bilateral large intestine 4 (li 4) points vs sham acupressure at bilateral proximal fourth interosseus space of the hand. secondary * to compare the duration of bmab, patient's rating of the procedure, and patient's willingness to receive acupressure during subsequent bmabs. outline: patients are stratified according to the number of prior bone marrow aspirations and biopsies (bmab) (0-1 vs ≥ 2) and type of procedure (bone marrow aspiration alone vs bmab). patients are randomized to one of two treatment arms. * arm i (acupressure): patients receive acupressure at bilateral large intestine 4 (li 4) points using haci magnetic acupressure suction cups (masc) during bmab. * arm ii (sham acupressure): patients receive acupressure at bilateral proximal fourth interosseus space of the hand using the same size masc as in arm i during bmab. patients in both arms also receive analgesic and anxiolytic medications as determined by the acupressure operator and physician. patients complete a questionnaire before and after bmab to assess pain experienced before and during bmab and their attitude towards the procedure.

Eligibility criteria:
disease characteristics: * diagnosis of cancer * scheduled to undergo a routine bone marrow aspiration with or without biopsy * no requirement for conscious sedation during the procedure patient characteristics: * not specified prior concurrent therapy: * see disease characteristics * no prior acupuncture or acupressure * no prior participation in this study

Keywords: pain hematopoietic/lymphoid cancer
an efficacy and safety study of pentasa in chinese patients with left-sided active ulcerative colitis followed by a 24-week open-label extension phase

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to investigate the efficacy and safety of 4-week double-blind treatment with pentasa enema compared with placebo enema in chinese patients with mild to moderate active left-sided ulcerative colitis, followed by a maximal 28-week open-label extension phase with pentasa enema and/or pentasa tablets.


Eligibility criteria:
inclusion criteria: * newly diagnosed or recurrent mild to moderate left-sided active ulcerative colitis * mayo score of at least 4 but not greater than 10 points and a score of ≥ 2 for colonoscopy * extent of colonic involvement and endoscopy subscore of mayo score as confirmed by colonoscopy * the patient is compliant with patient daily diary by having adequately responded to the questions on ≥5 of the most recent full 7 days before the randomization visit * negative stool test at screening to rule out parasites and bacterial pathogens exclusion criteria: * patients receiving \> 2g/day of oral 5-aminosalicylic acid (5-asa) products, or receiving topical rectal 5-asa \> 3g/week, within 7 days prior to screening * severe/fulminant ulcerative colitis or toxic dilatation of the colon * prior bowel resection surgery * patients allergic to 5-asa and derivative, any of the excipients, aspirin, or salicylates * patients with one or more of the diseases: bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis and crohn's disease * patients who are unable to fill in the patient daily diary or follow data-capturing procedures
vasoplegic syndrome in cardiac surgery

Conditions: Vasoplegic Syndrome of Cardiac Surgery

Summary: vasoplasmic syndrome in cardiac surgery is one of the major postoperative complications.this syndrome is characterized by persistent low blood pressure despite an optimization of preload and inotropism.


Eligibility criteria:
inclusion criteria: * all patients undergoing cardiac surgery with extracorporeal circulation * patients covered by a social insurance system. * patients who have given oral consent to participate after full information exclusion criteria: * cardiac graft. * preoperative ecmo / ecls. * cardiac assistance. * minor, * patient deprived of liberty, or under safeguard of justice.

Keywords: vasoplegicsyndrome cardiac surgery predictive risk score
study of 18 mg selincro® as-needed use, in the treatment of patients with alcohol dependence in primary care

Conditions: Alcohol Dependence

Summary: to determine the reduction in alcohol consumption in patients with alcohol dependence treated with 18 mg selincro® as-needed use, in conjunction with continuous psychosocial support in primary care

635 patients are planned (total number of patients) with 475 patients treated with selincro® (cohort a) and 160 patients not treated with selincro® (cohort b) to determine the reduction in alcohol consumption in patients with alcohol dependence. cohort a will comprise patients who maintain a high drinking risk level (drl, defined by world health organization (who) as \>60g alcohol/day for a man or \>40g alcohol/day for a woman), or above, in the period between the screening and inclusion visits. cohort b will comprise patients who reduce their alcohol consumption in the period between the screening and inclusion visits, that is, patients who do not maintain at least a high drl at the inclusion visit (and are therefore not eligible for treatment with nalmefene according to the smpc).

Eligibility criteria:
to ensure the study is broadly representative of primary care clinical practice, minimal inclusion and exclusion criteria are imposed with the main exclusion criteria relating to contraindications to the prescription of selincro® and reflecting the indication wording in the smpc. inclusion criteria: * the patient has alcohol dependence diagnosed according to icd-10. * the patient has had a high drl in the 4 weeks preceding the screening visit. * the patient is a man or woman, aged ≥18 years. * the patient provides a stable address and telephone number. exclusion criteria: * the patient has one or more contraindications to the prescription of selincro®: * hypersensitivity to the active substance or to any of the excipients * taking opioid analgesics * current or recent opioid addiction * acute symptoms of opioid withdrawal * recent use of opioids suspected * severe hepatic impairment (child-pugh classification) * severe renal impairment (egfr \<30 ml/min per 1.73 m2) * a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, or delirium tremens) * the patient has had \ 60g for men or \>40g for women) in the 4 weeks preceding the screening visit. * the patient has physical alcohol withdrawal symptoms and requires immediate detoxification for which inpatient treatment is required. * the patient is currently participating or has recently (in the 4 weeks preceding the screening visit) participated in a treatment or support programme for alcohol-use disorders, including alcohol anonymous, detoxification treatment, and treatment of alcohol withdrawal symptoms, or the patient is already taking nalmefene or has taken nalmefene in the 6 months preceding the screening visit.
belatacept in renal transplantation with intermediate risk maryland aggregate pathology index (mapi) scores

Conditions: End-Stage Renal Disease

Summary: this will be a pilot study to investigate the use of belatacept (bms) therapy in kidney transplant patients who have a mapi score of greater than or equal to 8. the mapi (maryland aggregate pathology index) score is a preimplantation donor scoring system which has five histopathological parameters that impact long-term kidney outcomes. many kidney transplant recipients use calcineurin inhibitors (cnis) as one of their anti-rejection medi cations. kidney function may be affected by anti-rejection medications known as calcineurin inhibitors (cnis). sometimes cnis can lead to toxicities and eventually loss of the kidney or episodes of chronic allograft nephropathy (can). avoiding cni immunosuppression and using belatacept therapy (bms) instead, may be associated with improved kidney transplant outcomes.


Eligibility criteria:
inclusion criteria: * male or female renal recipients 18-70 years of age undergoing primary kidney transplantation. * recipients of deceased donor (including expanded criteria donor organs and deceased donor organs after cardiac death) with mapi score ≥ 8. * cold ischemic time less than 40 hours at time of reperfusion. * negative serum pregnancy test for female patients. * patients who can understand the purposes and risks of the study, provide informed consent, and can comply with the treatment and follow-up requirements. exclusion criteria: * cold ischemic time (cit) \> 40 hours * patients who are sensitized with current pra\>40%, abo incompatible transplants, or t, or b cell crossmatch positive transplant. * patients without antibody to ebv * patients receiving multiple organ transplants. * patients unable to take oral medication at time of randomization * patient with a history of malignancy of any organ system, treated or untreated, within the past 2 years whether or not there is evidence of local recurrence or metastases, with the exception of carcinoma in situ * patients who tested positive for hiv, hepatitis c or hepatitis b surface antigen. * recipients of organs from donors who test positive for hiv, hepatitis c or hepatitis b surface antigen * patients with a clinically significant systemic infection within 30 days prior to transplant * patients who have cardiac failure at time of screening or any other severe cardiac disease as determined by the investigator * patients with abnormal laboratory findings of clinical significance within 2 weeks of randomization which would interfere with the objectives of the study. * females, pregnant or lactating, or are of childbearing potential unwilling to use an effective means of contraception or are planning to become pregnant. * patient with active tuberculosis infection

Keywords: kidney transplantation biopsy belatacept
long term efficacy of sacral nerve modulation (snm) in patients with constipation or stool incontinence

Conditions: Constipation; Fecal Incontinence

Summary: the aim of this study is to determine the success rate, the success duration, the complication rate, maintenance effort and quality of life several years after sacral nerve modulation (snm) treatment for constipation or stool incontinence.


Eligibility criteria:
inclusion criteria: * patients who had received an snm treatment in the last 10 years exclusion criteria: * pudendal nerve stimulation * refusal to allow use of clinical data for retrospective data analysis

Keywords: sacral nerve modulation quality of life stimulator maintenance snm